Protective outer enclosure for pharmaceutical vial

ABSTRACT

A protective outer container for a pharmaceutical vial includes a shell, a collar, and a cap that fit together to form a secure enclosure. The collar includes an outer wall having a lower region that fits into the mouth of the shell, and an upper region that fits into the cap. A plurality of resiliently deformable fins extends radially inwardly from the upper region of the collar outer wall. Each fin includes a gripping edge. The gripping edges together define an opening for receiving and gripping an upper portion of the vial. According to a further aspect of the container, the collar includes a flange extending outwardly from the collar outer wall, defining its upper and lower regions. Also described is a method for packaging a pharmaceutical vial, in which a shell, a collar, and a cap are used to provide a secure enclosure around the vial.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the priority benefit of U.S. ProvisionalApplication No. 60/733,225, filed Nov. 3, 2005, which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to improvements in the field of productpackaging, and more specifically to an improved protective outerenclosure for a pharmaceutical vial.

BACKGROUND OF THE INVENTION

Certain pharmaceuticals, such as drugs used in chemotherapy, aremanufactured in concentrated form, and are then sealed into individualvials for distribution to healthcare facilities. When a chemotherapydrug is used to treat a patient, a health worker must remove theconcentrated drug from a vial and prepare a dilution for intravenousadministration. In a typical hospital, chemotherapy drugs are handled bya relatively small number of people on the hospital's staff, who havereceived specific training in this area. Over the course of a year, itis not unusual for an individual staff member to handle hundreds ofvials of concentrated chemotherapy drugs.

Many chemotherapy drugs are cytotoxic materials that have medicinalvalue to patients. In their concentrated form, they typically requirespecial methods to handle and formulate, in order to minimize oreliminate exposure to the drug by health workers, such as pharmacists.However, for a number of reasons, even when precautions are taken, ahealth worker may nonetheless be exposed to chemotherapy drugs. Forexample, because these drugs are typically packaged in glass vials,there is a possibility that a vial may crack or be otherwise damagedduring the manufacturing process or in transit. A drug may leak out of adamaged vial onto other vials or onto packaging materials. Also, eventhough great care is taken during the manufacturing process, traceamounts of the drug are sometimes found on the outside of the vial.

Protective outer containers have been developed for pharmaceuticalvials. However, these containers suffer from a number of drawbacks.First, just as trace amounts of a chemotherapy drug may be found on theouter surface of a vial, trace amounts of the drug may also migrate ontothe outer surface of the protective container. Second, a vial musttypically be removed from the protective container in order to prepare adilution.

SUMMARY OF THE INVENTION

These and other issues are addressed by the present invention, oneaspect of which provides a protective outer container for apharmaceutical vial. The protective container includes a shell, acollar, and a cap that fit together to form a secure enclosure for apharmaceutical vial. The shell is preferably fabricated from a materialthat allows a health worker to visually inspect the vial withoutremoving it from the container. The collar includes an outer wall havinga lower region that fits into the mouth of the shell, and an upperregion that fits into the cap. A plurality of resiliently deformablefins extends radially inwardly from the upper region of the collar outerwall. Each fin includes a gripping edge. The gripping edges togetherdefine an opening for receiving and gripping an upper portion of thevial. According to a further aspect of the invention, the collarincludes a flange extending outwardly from the collar outer wall,defining its upper and lower regions. Another aspect of the inventionprovides a method for providing a protective enclosure for apharmaceutical vial.

Additional features and advantages of the present invention will becomeapparent by reference to the following detailed description andaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an isometric view of a protective outer container for apharmaceutical vial, according to a first aspect of the invention.

FIG. 2 shows a cross section of the container shown in FIG. 1 throughthe plane 2-2.

FIG. 3 shows an exploded view of the container shown in FIG. 1.

FIG. 4 shows a partially assembled view of the container shown in FIG.1.

FIG. 5 shows a plan view of the collar component of the container shownin FIG. 1.

FIG. 6 shows a cross section of the collar through the plane 6-6.

FIG. 7 shows a cross section of the collar through the plane 7-7.

FIG. 8 shows a plan view of the cap component of the outer enclosureshown in FIG. 1.

FIG. 9 shows a cross section of the cap through the plane 9-9.

FIG. 10 shows an isometric view of the container shown in FIG. 1 withthe cap removed, and with a dilution system fixture positioned above thecontainer.

FIG. 11 shows a flowchart of a method, according to a further aspect ofthe invention, for packaging a pharmaceutical vial in a protective outercontainer.

DETAILED DESCRIPTION

As used herein, the terms “vial” and “pharmaceutical vial” refergenerally to all vials, and like containers, that are used to packagepharmaceutical products, and the like. As will be apparent from thefollowing discussion, the present invention is not limited to aparticular type of vial. Also, although the present invention issuitable for use with chemotherapy drugs, it will be apparent that thepresent invention may be used to provide a protective outer enclosurefor any product distributed in a vial.

FIG. 1 shows an isometric view of a protective outer container 10according to a first aspect of the invention. FIG. 2 shows a crosssection of the container 10 through the plane 2-2, FIG. 3 shows anexploded view of the container 10, and FIG. 4 shows a partiallyassembled view of the container 10.

As shown in FIGS. 1-4, the container 10 includes a shell 20, a collar30, and a cap 40 that fit together to provide a protective enclosure fora vial 50 containing a pharmaceutical, or like product. As shown in FIG.4, the shell 20 and the collar 30 are assembled together to form anenclosure for the body of the vial 50, with the neck of the vial 50protruding upward through a central opening in the collar 30.

According a further aspect of the invention, the pharmaceutical vial 50is shipped from the factory fully enclosed by the protective outercontainer 10, as shown in FIG. 1. When the outer container 10 is openedby a health worker, only the cap 40 is removed. The body of the vial 50remains enclosed by the shell 20 and collar 30 during use and disposalof the vial 50.

The shell 20 is preferably fabricated from a material that allows ahealth worker to visually inspect the vial 50 without having to removeit from the container 10. As described in further detail below, theshell 20 may be fabricated from a suitable transparent plastic, or thelike. It will be seen in FIG. 1 that the structural components of theshell 20, collar 30, and cap 40 are shaped and positioned with respectto each other such that when a vial 50 is enclosed in the container 10,the body of the vial 50, including any label affixed thereto, is visiblethrough the shell 20.

Generally, the overall shape of the container 10 shown in FIGS. 1-4 iscylindrical. However, it will be apparent that it would be possible tomodify the overall shape of the container 10 without departing from thespirit of the invention. For example, the overall shape and size of thecontainer 10 may be modified to accommodate a vial 50 different from theone shown in FIGS. 1-4.

According to the present aspect of the invention, the shell 20, collar30, and cap 40 are held together in the assembled container 10 throughthe use of interlocking structures, and without the use of an adhesive.However, an adhesive may be used, if desired, particularly between theshell 20 and the collar 30. Generally speaking, it is desirable for theshell 20, collar 30, and cap 40 to be attached to each other in such away that a hospital worker can readily remove the cap 40 from the collar30 without causing the collar 30 to become separated from the shell 20.

In addition, an adhesive-backed plastic or paper tape (not shown) may beapplied to the exterior of the container 10 to provide further securityagainst accidental separation of the container components duringshipping and handling, and to show evidence of tampering. Also, theassembled and loaded container 10 may be shrink-wrapped or otherwiseencased. Further, it would be possible to modify some or all of theshell 20, collar 30, and cap 40 to include a breakaway strip or lockingstructure.

According to the present aspect of the invention, the shell 20 comprisesa cylindrical tube 21 to which there is attached a base 22 having aflat, circular portion that closes off the bottom of the tube. The base22 includes a foot 23, which provides clearance between the flat portionof the base 22 and the bottom edge of the tube 21. The top edge of thetube 21 forms a brim 24 defining a mouth 25 for receiving the vial 50and the bottom of the collar 30.

When the vial 50 is packaged into the container 10, the base of the vial50 rests on the upper surface of the shell base 22. The reason for thisarrangement is to provide stability to the vial 50 when it is used toprepare a dilution. Thus, it will be seen that the foot 23 providesprotection to the base of the vial 50.

It will be seen in FIGS. 1-4 that the diameter of the tube 21 is largerthan the diameter of the vial 50. Thus, there is some clearance betweenthe outer circumference of the vial 50 and the inner circumference ofthe shell tube 21. This clearance provides protection to the sides ofthe vial 50.

A suitable material for the shell 20 is polyethylene terepthalate (PET),with a thickness of 0.028 in. If PET is used, the base 22 may beattached to the tube 21 using sonic welding or other suitable technique.However, it will be understood that the shell 20 may be fabricated usingother techniques and materials without departing from the spirit of theinvention.

FIG. 5 shows a plan view of the collar 30. FIGS. 6 and 7 show crosssections of the collar through the planes 6-6 and 7-7, respectively.According to the present aspect of the invention, the collar 30 isfabricated from low-density polyethylene, using an injection moldingprocess. However, the material and technique used to fabricate thecollar 30 may be modified without departing from the spirit of theinvention.

The collar includes a circumferential outer wall 31, and a flange 32that protrudes outwardly from the outer wall 31. The collar flange 32serves a number of purposes, including providing a gripping surface thatis useful both for loading the vial 50 into the container 10 and alsofor subsequently separating the cap 40 from the collar 30.

The flange 32 divides the outer wall 31 into a lower region 31 a and anupper region 31 b. The outer wall's lower region 31 a is shaped tosnugly fit within the shell mouth 25. When the collar 30 is mounted ontothe shell 20, the shell brim 24 butts up against the lower surface ofthe collar flange 32. In addition, there is formed in the bottom surfaceof the flange 32 a circumferential channel 33. When the collar 30 ismounted onto the shell 20, the shell brim 24 seats firmly within thechannel 33, helping to create a firm attachment between the shell 20 andcollar 30.

The wall's lower region 31 a includes a pair of substantiallyrectangular cutout regions 34, which help provide visibility of the bodyof a vial 50 packaged in the assembled container 10. The wall's lowerregion further includes circumferential ridges 35 that serve tostrengthen the attachment between the shell 20 and collar 30.

The collar wall's upper region 31 b is shaped to snugly fit within thecap opening 44 (FIG. 9). When the cap 40 is mounted onto the collar 30,the cap brim 43 (FIG. 9) butts up against the upper surface of thecollar flange 32. A bevel 36 is provided at the top of the collar outerwall 31 to facilitate the mounting of the cap 40 onto the collar 30.

Extending radially inwardly from the upper edge of the collar wall 31 isa plurality of resiliently deflectable fins 37. Each fin 37 includes anarcuate, concave gripping edge 38. The respective gripping edges 38 ofall of the fins 37 combine to define a substantially circular opening 39for receiving the neck of the vial 50. It will further be seen in FIG.5, that the fins 37 are arranged such that open spaces 310 are providedbetween adjacent fins 37. At least part of each open space 310 remainsunobstructed, even after the collar 40 has been mounted onto a vial 50.

The fins 37 are sloped to generally follow the contour of the shoulderregion of the vial 50. The sloping of the fins 37 creates a funnel-likeshape that facilitates the installation of the collar 30 onto the vial50. In addition, the sloping of the fins 37 allows the collar 30 to holdthe vial 50 more securely, and also tends to prevent the collar 30 frombeing pulled free of the vial 50.

The collar 30 further includes a plurality of vertical ribs 311 that areextend along the interior surface of the collar outer wall 31. Thestructure of the ribs 311 is illustrated in FIG. 7, which is a crosssection of the collar 30 through the plane 7-7. The ribs 311 addrigidity to the collar outer wall 31, which tends to enhance thestrength of the attachment of the collar 30 to the shell 20. It shouldbe noted, however, that it has been found that it is possible tofabricate a collar outer wall 31 having sufficient rigidity without theuse of the vertical ribs 311.

As shown in FIGS. 1-4, the lip of the vial 50 has a larger diameter thanthe neck of the vial 50. Thus, it will be seen that when the collar 30is installed onto the vial 50, the fins 37 must deflect out of the wayto allow the lip of the vial 50 to pass through the collar opening 39.The resilience of the fins 37 causes them to tend to return to theiroriginal angle, thereby allowing the fin's gripping edges 38 to grip theneck of the vial 50. In order to improve the grip between the collar 30and the vial 50, it is desirable for the diameter of the opening 39 tobe somewhat smaller than the diameter of the neck of the vial 50. Thus,in the assembled package, the fins 37 are in a slightly deflectedcondition, causing them to pinch the neck of the vial 50.

FIG. 8 shows a plan view of the cap 40, and FIG. 9 shows a cross sectionof the cap 40 through plane 9-9. According to the present aspect of theinvention, the cap 40 is fabricated from low-density polyethylene, usingan injection molding process. However, the material and technique usedto fabricate the cap 40 may be modified without departing from thespirit of the invention.

The cap includes a top 41 and a circumferential wall 42. The bottom edgeof the wall forms a brim 43 defining an opening 44 that fits snuglyaround the upper region 31 a of the collar outer wall 31. When the cap40 is mounted to the collar 30, the cap brim 43 butts up against theupper surface of the collar flange 32. Because the cap 40 is fabricatedusing an injection molding technique, a small gate well 45 is formed onthe lower surface of the top 41.

The cap 40 further includes a flange 46 proximate to the top 41. In theassembled container 10, the cap flange 46 is substantially parallel tothe collar flange 32. One purpose served by the two flanges 32 and 46 isto provide handy gripping surfaces that allow a hospital worker toeasily remove the cap 40 from the container 30, without accidentallycausing the collar 30 to separate from the shell 20.

According to a further aspect of the invention, the collar flange 32 andthe cap flange 46 are provided with rounded edges, to lessen thepossibility that hospital workers may accidentally damage their gloveswhen gripping the flanges 32 and 46 to open the container 10. Accordingto this aspect of the invention, the vertex formed by the upper andcircumferential surfaces of the collar flange 32, and the vertex formedby the lower and circumferential surfaces of the cap flange 46, are eachprovided with a radius (not shown), such that the vertices are rounded.

Once the cap 40 has been removed, a hospital worker may then use thevial 50 to prepare a dilution. FIG. 10 shows an isometric view of thecontainer 10, in which the cap 40 has been removed, and in which the topof the vial 50 includes an exposed, pierceable membrane 51. Also shownin FIG. 10, positioned over the container 10, is a fixture 60 used in adilution system known as the PhaSeal system, manufactured by CarmelPharma AB, and described in U.S. Pat. No. 6,343,629. The bottom of thePhaSeal fixture 60 is shaped to fit over the top of the vial 50, andincludes a hollow needle 61 that is inserted through the membrane 51 toextract the contents of the vial 50. The fixture 60 includes a pluralityof long projections 62 and short projections 63 that extend downwardaround the lip and neck of the vial 50.

As shown in FIG. 10, the open spaces 310 between the fins 37 correspondin position to the long projections 62 of the fixture 60. Thus, bysuitably rotating the container 10 relative to the fixture 60, it ispossible to install the fixture 60 onto the vial 50 without having toremove the vial 50 from the shell 20 and collar 30. It should be notedthat although the present aspect of the invention is described withrespect to the PhaSeal fixture, it will be apparent that the collar 30may be modified to accommodate other type of fixtures, without departingfrom the spirit of the invention.

The container 10 provides protection to the vial 50 against impactsduring shipping and handling, and also serves a number of otherpurposes. As discussed above, health workers should have minimal or nodirect contact with certain pharmaceutical products, such aschemotherapy drugs, particularly in their undiluted form. It is possiblefor a vial to crack or otherwise develop a leak that may not be apparentto a health worker until the worker has already begun to handle thevial. The transparent shell 20 of the container 10 described hereinallows a health worker to visually inspect the vial 50 for cracks andleaks without directly handling the vial 50. In addition, a healthworker may detect a leak by noticing an accumulation of pharmaceuticalproduct at the base of the shell 22.

Beyond the issue of leakage, there is another significant issue to beaddressed. Even when great care is taken during manufacturing,packaging, shipping, and handling, and even when there is no readilydetectible leak in a vial, it is nonetheless possible for trace amountsof a drug to contaminate the outer surface of the vial. Trace amounts ofthe drug may also migrate to packaging materials, countertops, etc. Itis desirable to minimize or eliminate exposure to the drug by healthworkers, for example, minimizing repeated exposure to trace amounts ofthe drug residing on the outer surface of the vial.

To address this issue, there have been developed protective outercontainers for pharmaceutical vials. However, even when using one ofthese outer containers, there is a risk that some of the pharmaceuticalproduct may contaminate the exterior surfaces of the protective outercontainer.

Using a container according to the present invention, it is possible fora manufacturer to load and seal a vial 50 into the container 10, and fora hospital worker to prepare a dilution from the container 10, withoutever directly touching the vial 50. Thus, using the container 10, ispossible to eliminate most, if not all, contamination pathways.

FIG. 11 shows a flowchart of a method 100 according to the presentinvention for packaging a pharmaceutical vial into a protective outerenclosure. In step 101, a collar is provided, such as the collar 30illustrated in FIGS. 5-7, discussed above. In step 102, the collar ismounted onto a vial, holding only an exterior surface of the collar. Forexample, the vial could be placed onto a conveyor belt, countertop, orother suitable work surface. A worker, or an automated machine, couldthen manipulate the collar, touching only an exterior surface thereof,and lower the collar such that the neck of the vial passes through thecollar's central opening.

Once the collar has been installed, the pinching action of theresiliently deformable fins then allows the vial to be lifted from thework surface, again only touching an exterior surface of the collar. Instep 103, the collar is used in this manner to load the vial into ashell, taking care to make sure that no exposed surface of the vialmakes contact with the exterior of the shell.

In step 104, once the vial has been loaded into the shell, the collarcan then be sealed to the shell by fitting it into the shell mouth, andseating the shell brim into a receiving channel in the collar. In step105, once the collar has been sealed to the shell, the cap may then bemounted onto the collar, thereby securely enclosing the vial. Once thevial has been safely loaded into the protective outer container, thevial and container can be further packaged, as described above.

As noted above, while the present invention has been described withrespect to pharmaceutical vials containing chemotherapy drugs, it willbe apparent that the present invention is not limited to this particularcontext. The described system may be used to provide a protective outerenclosure for other types of containers and substances without departingfrom the spirit of the invention.

While the foregoing description includes details that will enable thoseskilled in the art to practice the invention, it should be recognizedthat the description is illustrative in nature and that manymodifications and variations thereof will be apparent to those skilledin the art having the benefit of these teachings. It is accordinglyintended that the invention herein be defined solely by the claimsappended hereto and that the claims be interpreted as broadly aspermitted by the prior art.

1. A container for a pharmaceutical vial, comprising: a shell having amouth for receiving a lower portion of the vial; a collar including anouter wall, a lower region of which fits snugly into the mouth of theshell, the collar further including a plurality of resilientlydeformable fins extending radially inwardly from an upper region of thecollar outer wall, each fin including a gripping edge, the grippingedges together defining an opening for receiving and gripping an upperportion of the vial; and a cap including an opening that fits snuglyover the upper region of the collar outer wall, the shell, collar, andcap together forming a sealed enclosure around the vial.
 2. Thecontainer of claim 1, wherein the shell is fabricated from a materialallowing a health worker to visually inspect the vial without removingit from the container.
 3. The container of claim 1, wherein the openingdefined by the gripping edges of the undeflected fins is smaller thanthe upper portion of the vial, such that when the vial is enclosed inthe container, the deflection and resilience of the fins causes them topinch the upper portion of the vial.
 4. The container of claim 1,wherein the collar further comprises: a flange extending outwardly fromthe collar outer wall, the flange defining the upper and lower regionsof the collar outer wall and including a lower surface that butts upagainst the mouth of the shell when the shell is mounted to the collar,and an upper surface that butts up against the cap opening when the capis mounted to the collar.
 5. The container of claim 4, wherein the lowersurface of the circumferential flange includes a channel that is shapedto closely receive the mouth of the shell.
 6. The container of claim 1,wherein the fins are sloped to follow a contour of the pharmaceuticalvial.
 7. The container of claim 6, wherein the opening defined by thefins is shaped to receive and grip a neck region of the vial, andwherein the fins are sloped to follow the contour of a shoulder regionof the vial.
 8. The container of claim 7, wherein the collar includes aplurality of interior vertical ribs.
 9. The container of claim 1,wherein the shell includes a substantially flat base.
 10. The containerof claim 9, wherein a base region of the vial rests on the base of theshell when the vial is enclosed in the container.
 11. The container ofclaim 9, wherein the shell comprises a tube with a welded base.
 12. Thecontainer of claim 1, wherein the lower region of the outer wallincludes at least one cutout section.
 13. The container of claim 12,wherein the cutout section has a substantially rectangular shape. 14.The container of claim 4, wherein the cap includes a flange extendingoutwardly from an upper region of the cap.
 15. The container of claim 1,wherein the sealed enclosure is substantially cylindrical in shape. 16.The container of claim 1, wherein the fins are spaced apart from eachother to define there between a plurality of open spaces.
 17. Thecontainer of claim 16, wherein the plurality of open spaces between thefins corresponds in position to a plurality of projections extendingfrom a fixture, thereby allowing the fixture to be installed onto thevial without removing the collar therefrom.
 18. A method for providing aprotective enclosure for a pharmaceutical vial, comprising: providing acollar having an outer wall and a plurality of resiliently deformablefins extending inwardly from the collar outer wall, each fin including agripping edge, the gripping edges together defining an opening forreceiving and gripping an upper portion of the vial; mounting the collaronto the vial, while holding an exterior surface of the collar, wherebyonly the fins of the collar make direct contact with the vial; using thecollar to load the vial into a shell through a mouth thereof, the collarincluding a lower region that fits snugly into the mouth of the shell;mounting the collar to the shell by fitting the lower region of thecollar into the mouth of the shell; and mounting a cap to the collar.19. The method of claim 18, wherein the collar includes a flange thatextends outwardly from the collar outer wall, and wherein the step ofmounting the collar to the shell includes butting the mouth of the shellup against a lower surface of the flange; and the step of mounting a capto the collar includes butting the cap up against an upper surface ofthe flange.
 20. The method of claim 19, wherein the lower surface of theflange includes a channel shaped to closely receive the mouth of theshell, and wherein the step of mounting the collar to the shell includesfitting the mouth of the shell into the receiving channel in the collarflange.